Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire
NCT ID: NCT03985085
Last Updated: 2022-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2019-11-26
2023-06-30
Brief Summary
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Detailed Description
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It consists in the implementation of a comprehensive sexual and reproductive health care package for female sex workers in Côte d'Ivoire, combining an HIV PrEP offer (for HIV- FSW) with early treatment of HIV+ FSW, management of HBV infection (testing, vaccination and treatment), testing and treatment of sexually transmitted infections (STIs) and their consequences, a contraception offer, a quarterly screening of pregnancies, menstrual management counselling and identification of addiction.
This healthcare package will be available both in mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and in the fixed clinic of the partner community-based NGO, at the discretion of each female participant.
The main objective is to develop, document and analyze a community-based healthcare package combining testing, prevention tools including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of Hepatitis B virus and sexual and reproductive health (SRH)
Specific objectives are:
1. To analyse access to care and retention into care, and more generally female participants' healthcare trajectories through a quarterly follow-up of FSWs (infected with HIV or not)
2. To measure female participants' health outcome over time of clinical, behavioural and social indicators
3. To assess PrEP initiation, use and adherence
4. To compare HIV management in the PRINCESSE system with the existing routine treatment and care
5. To measure HBV testing, vaccination and treatment, as part of a decentralised management integrated with HIV PrEP, and possible interactions between HIV PrEP and HBV infection
6. To document the unexpected consequences (positive or negative) of PRINCESSE system on the everyday life of female participants in particular, and on the sex industry in general
7. To evaluate the impact of vaginal microbiota on bacterial sexually transmitted infections, human papillomavirus (HPV) infections and associated cervical lesions; the impact of the HPV type distribution on the vaccinal strategy and the added value of HPV PCR for the primary screening of cervical cancer; and the impact of antimicrobial resistance on the STI guidelines.
8. Assess the a priori acceptability and appropriateness of different forms of long-acting PrEP for different sex workers profiles.
Four data collection devices are included in the cohort: (i) clinical and safety data, (ii) socio-behavioural questionnaires, (iii) biological data, and (iv) in-depth interviews with female participants.
Eight additional data collections are scheduled outside the cohort itself: (i) capture of medical and activity records of Aprosam for PRINCESSE participants; (ii) capture of medical records of HIV+ FSW patients not participating in the PRINCESSE cohort and routinely examined by the NGO partner; (iii) in-depth interviews with key informants in the FSW community; (iv) in-depth interviews with PRINCESSE follow-up actors (peer educators and caregivers) (v) individual biographical interviews with female sex workers recruited by Aprosam and Espace Confiance about long-acting PrEP, supplemented by (vi) focus group discussions with female sex workers; (vii) focus group discussions with sex workers assigned men at birth; (viii) individual interviews with community actors.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention arm
Comprehensive package of sexual and reproductive health services
Implementation of a comprehensive sexual and reproductive health care package for female sex workers in Côte d'Ivoire, combining an HIV PrEP offer (for HIV- FSW) with early treatment of HIV+ FSW, management of HBV infection (testing, vaccination and treatment), testing and treatment of sexually transmitted infections (STIs) and their consequences, a contraception offer, a quarterly screening of pregnancies, menstrual management counselling and identification of addiction.
This healthcare package will be available both in mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and in the fixed clinic of the partner community-based NGO, at the discretion of each female participant.
Interventions
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Comprehensive package of sexual and reproductive health services
Implementation of a comprehensive sexual and reproductive health care package for female sex workers in Côte d'Ivoire, combining an HIV PrEP offer (for HIV- FSW) with early treatment of HIV+ FSW, management of HBV infection (testing, vaccination and treatment), testing and treatment of sexually transmitted infections (STIs) and their consequences, a contraception offer, a quarterly screening of pregnancies, menstrual management counselling and identification of addiction.
This healthcare package will be available both in mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and in the fixed clinic of the partner community-based NGO, at the discretion of each female participant.
Eligibility Criteria
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Inclusion Criteria
* Self-reporting as being a sex worker
* Wishing to enrol in a regular clinical follow-up
* Agreeing to participate in the study and signing the informed consent form
* Regardless of HIV status (infected or not)
* Whether or not the participant has already taken antiretrovirals
* Whether or not the participant is already followed by Aprosam
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Programme PAC-CI
UNKNOWN
Aprosam, San Pedro
UNKNOWN
Institut de Recherche pour le Developpement
OTHER_GOV
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Joseph Larmarange, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche pour le Développement (IRD)
Sege Eholié, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Programme PAC-CI
Locations
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Aprosam
San-Pédro, , Côte d’Ivoire
Countries
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Central Contacts
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Facility Contacts
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References
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Becquet V, Nouaman M, Plazy M, Agoua A, Zebago C, Dao H, Montoyo A, Jary A, Coffie PA, Eholie S, Larmarange J; the ANRS 12381 PRINCESSE team. A community-based healthcare package combining testing and prevention tools, including pre-exposure prophylaxis (PrEP), immediate HIV treatment, management of hepatitis B virus, and sexual and reproductive health (SRH), targeting female sex workers (FSWs) in Cote d'Ivoire: the ANRS 12381 PRINCESSE project. BMC Public Health. 2021 Dec 4;21(1):2214. doi: 10.1186/s12889-021-12235-0.
Other Identifiers
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ANRS 12381 PRINCESSE
Identifier Type: -
Identifier Source: org_study_id
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